Betamethasone valerate dressing is non‐inferior to calcipotriol–betamethasone dipropionate ointment in the treatment of patients with mild‐to‐moderate chronic plaque psoriasis: results of a randomized assessor‐blinded multicentre trial
| Autor: | V. Frangione, A. Grodzińska, Luigi Naldi, Sergio Chimenti, M. Esposito, M. Kapińska‐Mrowiecka, Ortonne Jp |
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| Rok vydání: | 2013 |
| Předmět: |
Male
medicine.medical_specialty Anti-Inflammatory Agents Betamethasone dipropionate Dermatology Placebo Betamethasone law.invention Ointments chemistry.chemical_compound Calcitriol Randomized controlled trial law Psoriasis Internal medicine medicine Humans Single-Blind Method Prospective Studies Glucocorticoids Calcipotriol Betamethasone Valerate business.industry Original Articles Middle Aged medicine.disease Bandages Betamethasone valerate Surgery Infectious Diseases Tolerability chemistry Chronic Disease Drug Therapy Combination Female Dermatologic Agents business medicine.drug |
| Zdroj: | Journal of the European Academy of Dermatology and Venereology |
| ISSN: | 1468-3083 0926-9959 |
| Popis: | Background A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP). Methods This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol–betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients’ quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group. Results Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a −0.288 (95% CI: −0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group. Conclusions BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP. Both treatments significantly improve patients’ psoriasis and QoL. |
| Databáze: | OpenAIRE |
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